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  • LifeVest
  • Clinical Outcomes SCD-PROTECT
    • zoll-life-vest

    Clinical Outcomes: SCD-PROTECT

    High SCA treatment rates during early period of contemporary GDMT in 19,598 consecutive LifeVest patients (NICM and MI/CAD)

         Cardiologist sitting and talking with a LifeVest wearable cardioverter defibrillator patient

    Sudden cardiac arrest in patients with newly diagnosed non-ischemic cardiomyopathy or myocardial infarction/coronary artery disease – Nationwide analysis of more than 19,500 patients with a wearable cardioverter-defibrillator (SCD-PROTECT)

    Duncker, David1; Marijon, Eloi2; Metra, Marco3; Piot, Olivier4; Fudim, Marat5; Siebert, Uwe6; Frey, Norbert7; Maier, Lars Siegfried8; Bauersachs, Johann1

    Objectives

    • The SCD-PROTECT study was an analysis of >19,500 consecutive patients in Germany with non-ischemic cardiomyopathy (NICM) or myocardial infarction/coronary artery disease (MI/CAD) and reduced left ventricular ejection fraction (LVEF), using a LifeVest® wearable cardioverter defibrillator (WCD) to evaluate the current SCA/SCD risk in this early phase.
    • Primary outcome was SCA/SCD incidence, measured by appropriate treatments delivered and automatically recorded by the LifeVest WCD.

    Methods

    • Epidemiological, observational, multicenter study
    • Nationwide analysis of all patients between December 2021 and May 2023 who wore a LifeVest WCD
    • Consecutive cohort of 19,598 patients
    • The outcome is presented as cumulative incidence per 100 patient-years, respectively
    SCD PROTECT Medical Therapy at discharge

    Patient Characteristics and Indications

    • WCD start was associated with high utilization of contemporary GDMT at hospital discharge in both NICM and MI/CAD (see table). 
    • Patients: n=19,598
      • Male: 79.3% (n=15,545)
      • Female: 20.7% (n=4,053)
    • Age:
      • NICM: 58.6 (+/- 13.7)
      • MI/CAD: 64.2 (+/- 10.6)
    • Indications:
      • NICM: n=11,449
      • MI/CAD: n=8,149
    • LVEF at Baseline:
      • NICM: 26.9%
      • MI/CAD: 28.4%
    Graph showing cumulative SCA and SCD incidence per 100 patient-years in NICM and MI patients

    Clinical Results

    • Despite wide overall use of GDMT in both NICM and MI/CAD, incidence of appropriate LifeVest treatments was high.
    • Cumulative incidence of SCA/SCD in 100 patient-years:
      • 6.53 in NICM
      • 9.18 in MI/CAD
    • Median LifeVest Wear Time® per day was 23.4 and 23.5 hours in NICM and MI/CAD patients, respectively.
    • Inappropriate treatments were rare with an overall rate of 0.5%.
    • Mean LVEF at baseline was 26.9 (+/- 10.3) for NICM and 28.4 (+/- 8.0) for MI patients and improved to above 35% in both groups (38.9% (+/- 10.8) and 38.3% (+/- 9.9)).

    “There is a high risk of SCA or SCD within the first month after diagnosis of reduced LVEF, despite the fact that there was broad use of the fantastic four.”

    -Johann Bauersachs, SCD-PROTECT investigator, discusses results with Radcliffe Cardiology

    Conclusions

    • The German nationwide SCD-PROTECT study is the largest WCD study to date.
    • Despite wide utilization of GDMT, the risk of SCA/SCD is high during the early medical therapy optimization for reduced LVEF in patients with NICM and MI/CAD patient groups.
    • The incidence of SCA/SCD per 100 patient-years was considerably higher than seen in ICD trials in chronic HFrEF patients.
    • The majority of patients' LVEF improved beyond 35%.

    Source: Duncker D, Marijon E, Metra M, Piot O, Fudim M, Siebert U, Frey N, Maier LS, Bauersachs J. Sudden cardiac arrest in patients with newly diagnosed non-ischemic cardiomyopathy or myocardial infarction/coronary artery disease – Nationwide analysis of more than 19.000 patients with a wearable cardioverter-defibrillator. Presented by Johann Bauersachs as Late-Breaking Clinical Trial at European Society of Cardiology Heart Failure 2025. May 18, 2025.

    1 Hannover Medical School, Department of Cardiology and Angiology, Hannover Heart Rhythm Center, Germany
    2 European Hospital Georges-Pompidou, Cardiology Division, Paris, France
    3 Hospital of Brescia, Cardiology Division, Brescia, Italy
    4 North Cardiological Center, Saint-Denis, France
    5 Division of Cardiology, Duke University Medical Center, Durham, North Carolina
    6 UMIT TIROL – University for Health Sciences and Technology, Department of Public Health, Health Services Research and Health Technology Assessment, Hall in Tirol, Austria
    7 University Hospital Heidelberg, Department of Cardiology, Angiology, Pneumology, Heidelberg, Germany
    8 University Hospital Regensburg, Internal Medicine II, Germany

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